FBAE’S Contribution to FAO Conference on GMOS

The following comments were written by Professor Professor C Kameswara Rao, Executive Secretary, Foundation for Biotechnology Awareness and Education, Bangalore, India. Ph: 91-80-6549470, 6534740; E-m: krao@vsnl.com; FBAE Website: www.fbae.org, in connection with the FAO Electronic Conference on GMOs, conducted during April-June 2003.   Most are original but some were written in response to questions raised by other participants of the conference.

Some like on Allergy were not taken as the moderator considered them as outside the scope of the conference coverage or that they may invite issues not intended to be covered by the conference.

3.  Message No.  41:

Re: Financial/time costs of GE crops

This is Tracey McCowen again.

 I would like to comment on message 37 (May 9) by Dr. Rao. If I understand
 Dr. Rao correctly, he is suggesting that "reduce[d] trial phase duration for
 repeated transgenic events" are needed. I can see two problems with this
 point of view.

 The first is economical, if the pioneering product must undergo a more
 lengthy trial phase it will deter companies seeking to be the first with a
 novel trait. The first regulated GE product on the US market, the Flavr
Savr  tomato, proved this.

The second point I take issue with is if the professor is suggesting that
a  repeated transgenic event is the same across different species, I would
answer that they most certainly are not. Take for instance different
pollen  weights, canola (mustard or rape) and maize (corn) are vastly different,
thus creating very different scenarios for risks associated with
pollination.

Tracey McCowen MBE,  Kingswood Farm,  1314 King-Vaughan Rd,
Maple, ON L6A 2A5,  Canada,  tmccowen@yahoo.com

 4.  Message No. 46:

From C Kameswara Rao:

Pioneering product must undergo the required length of  or even extended,
trial phases.   Even this should have a reasonable time frame, with reasons
explained for extended periods.   Repeated events in the same crop need not
necessarily be subjected to the same lengthy process.    If it is Cry 1Ac in
cotton, whoever is producing the same event in the same crop, is my point.
It is not necessary to repeat evry experiment on biosecurity in every
country.

I have worked on pollen for a considerable period of time and I am aware the
dynamics of pollen drift and that this is not the same for every crop and
gene flow considerations are not the same in every country.

5. Message No. 43: GMO, GEO and LMO

This is from Professor C Kameswara Rao, Bangalore, India.

On reading some of the messages posted, I felt a need to point out the loose
use of terms GMO, GEO and LMO and the question of application of regulatory
processes.  

Genetic Modification:

All the organisms deployed in agriculture and animal husbandry today are the
products of Genetic Modification for over 10,000 years. Initially, suitable
varieties were 'selected' for the desirable characteristic from domesticated
wild plants and animals. Some of the traits have surfaced in the genetic
diversity of the concerned species through natural hybridisation and natural
mutation, and were subjected to selection. Selection is the most important
tool of both conventional and modern agricultural practice, both
constituting biotechnology. Subsequently, artificial hybridisation has
resulted in several crop plant varieties. Natural or artificial,
hybridisation is possible only between organisms that are biologically
closely related. Mutations induced by any one of several physical or
chemical means were also a rich source of genetic diversity. Varieties of
corn, wheat, sugarcane, cotton and several others involved hybridisation,
while some like rice were based only on selection.   This conventional means
of producing Genetically Modified Organisms (GMOs) involves sexual
reproduction. It constitutes vertical transfer of genes and the genes
concerned express only in the next generation.

Genetic Engineering and Transgenic plants:

Under the conventional plant breeding procedures, genes from an organism can
be introduced only into another biologically closely related organism, such
as two varieties of the same crop and possibly, in exceptional circumstances
between two species of the same genus. In nature such events do occur but
are rare.  

Exchange of genes between biologically totally unrelated organisms does not
occur in nature. Using techniques of genetic engineering, now genes selected
from a bacterium are inserted into the genome of a crop plant or human genes
into bacteria. These are the Genetically Engineered Organisms (GEOs), also
called transgenic organisms. Genetic engineering constitutes lateral (or
horizontal) transfer of genes and the genes can express in the same
generation.

Some examples of the transgenic technology are incorporation of

a) genes for the insecticidal proteins of bacteria into the genomes of
several crop plants such as tobacco, corn, potato, rice, cotton, etc.,
b) genes for the synthesis of b-carotene from daffodil and a bacterium into
rice,
c) genes for human milk proteins into rice,
d) genes for human insulin into bacteria and
e) genes for human haemoglobin into tobacco plants.  

The term Living Modified Organisms (LMOs) is applicable to both GMOs and
GEOs.  

The fact that crop and animal varieties produced through the conventional
means also involve genetic modification has not been appreciated with the
degree of seriousness it deserves and the terms GMOs and LMOs have come to
be applied only to Genetically Engineered Organisms (GEOs). In order to
convey precisely, we should apply the term LMO to both conventionally
induced genetic modification (GMO) and the transgenics induced through
genetic engineering (GEO), and distinguish between the latter two.

Governmental Regulatory Processes:

There is no technology without risks. GMOs also are fraught with risks
similar to those attributed to GEOs. A long time ago, I have seen with
dismay, the kind and degree of variation that appeared on continued selfing
and on exposure to gamma irradiation, in pearl millet. Some of the
characters that surfaced throw overboard the taxonomic concepts of, not only
Pennisetum americanum (= Pennisetum typhoideum), but even that of the family
Poaceae. Some of this variation easily qualifies to be called monstrosities.
No one ever considered that genetic modification by conventional means risky
at all. Considering their potential risks of biosecurity, GMOs also should
be subjected to the same rigorous regulatory processes as GEOs, but they are
not.

6. Message No. 47: This is from Julie Newman, Australia.

In response to Professor Kameswara Rao's comment (Message 43, May 10), "All
the organisms deployed in agriculture and animal husbandry today are the
products of Genetic Modification for over 10,000 years.":

It is very unfortunate that the misleading terminology of "genetic
modification" was ever given, much less adopted, in reference to transgenics
or the processes explained as GEO. "Modification" means change and hence the
term does not specify how the genetic change took place. While Professor Rao
is technically correct with his definition clarification, it should be noted
that governments around the world have adopted an incorrect term and the
terms GMO and GEO are deemed to refer to "recombinant DNA" processes. [GMO =
Genetically Modified Organism; GEO = Genetically Engineered
Organism...Moderator].

Referring to the technically correct terminology is perhaps a very critical
issue that should be addressed in the formulation of any legislation.

Julie Newman, Network of Concerned Farmers, Newdegate, West Australia
www.non-gm-farmers.com, newseeds (at) treko.net.au

7. Message No. 52:

8. Message No. 53:

9.  Message No. 54:

This is from C Kameswara Rao, Bangalore, India, responding to Message 53,
May 16, of Tracey McCowen.

Peer review is certainly very necessary. I know of technologists opposing
some aspects of biotechnology. But most people who agitate against
technology do not qualify to be called 'peers' since they have no background
of scientific and technical aspects of the issues and implications. They
have reasons other than the risks of technology, to oppose technology. Then,
for peer review, the data should be made available to the scientific
community and the interested public, and not considered only by a closeted
committee,  shrouded in secrecy, and not giving reaasons for deferring
decisions or asking for extended trial periods.

I do not mean any offense to the scientific community that has reasons to
oppose technology. I myself oppose a number of aspects of biotechnology.

I am surprised that Dr McCowen understands the term 'anti-tech lobbies' as
being used to describe those people in science questioning the way the
technology is being applied. This assumption is not correct. There are
anti-tech lobbies throughout the world, constituted of people with no
science background and they pressurise the governments and regulatory
committees, directly or indirectly, at every step, from import of GE
products, permitting for field
trials and to release for commercial cultivation, when the safer option is
deferrment.

I cited examples from the Indian situation to indicate the frequent and
unwarranted use the Precautionary Principle. In the case of GE mustard in
India, the Review Committee for Genetic Modification had no negative
observations on the performance of GE variety but the approval for field
trials was deferred twice. [Presumably, the reference is to the Review
Committee on Genetic Manipulation under the Department of Biotechnology,
Ministry of Science and Technology, see Message 14, May 5, by Ramesh V.
Bhat...Moderator]. Factors such as gene flow, weediness, yield in terms of
seed and oil content, have all been examined and nothing that warrants
extended field trials was evident. The Bt cotton variety for north Indian
states has been deferred twice, the second time on account of it being
susceptible to leaf curl virus, which is the case with every variety of
cotton grown in India, including the isogenic of the Bt variety in question.
If the logic is extended, no variety of cotton should be grown in India. Bt
technology has nothing to do with inducing or preventing the disease caused
by the leaf curl virus.

I support the application of the Precautionary Principle during regulatory
processes but not its overuse or misuse.


10. Message No. 56:

This is Glenn Ashton again.

An interesting contradiction emerges in recent posts.

On the one hand. the argument is made that the precautionary principle (PP)
is abused by opponents to technology, in reference to groups that have taken
a strong regulatory line with transgenic products. (C Kameswara Rao;
Messages 52 (May 14) and 54 (May 16)).

On the other hand, Dick Richardson (Message 51, May 13) makes an elegant
case around insufficient genetic information, indirectly showing the need
for the PP. Given this lack of information and indeed, if Richardson's
submission is read alongside Barry Commoners article, "Unraveling the DNA
Myth: The Spurious Foundation of Genetic Engineering", published in the
February 2002 issue of Harper's Magazine (full references and background at
http://www.criticalgenetics.org/), it is clear that opposition to pressure
to introduce GE foods and crops - by an emphasis on substantial equivalence
and other scientifically questionable assumptions - is indeed founded upon
real scientific concerns. This aspect underlines the real need for the PP.

Moreover, concerns around poor regulation of transgenics are not only
scientific; there are also economic (liability and intellectual property),
political (responsibility), social (ownership and gender impacts),
environmental (ecology) and other concerns that must be regulated. It is
therefore insufficient to regulate this technology only by scientific
criteria. Far more worryingly, in light of the above references it becomes
increasingly clear that the dominant paradigm of the central dogma, coupled
to Cricks' sequence hypothesis, each, jointly and separately, fail to stand
up in practice. That these outdated concepts form a basis for present
assumptions for claims of safety and testing, whilst using a model more
suited to chemical safety than genomic safety, is unacceptable.

Certainly, we need to use certain scientific criteria to regulate
transgenics, but we must move away from the present emphasis on flawed
theoretical frameworks that are manipulated by powerful lobby groups to suit
their own narrow ends. We all know that statistical analyses can easily be
abused. Given the international scope of revolving door regulation, in which
the de facto lead international regulators (The United States' Environmental
Protection Agency (EPA) and Food and Drug Administration (FDA) among others)
are especially compromised by their close associations with industry and the
implications of negative influences on meaningful regulation are
highlighted.

Regulations must regulate, not facilitate. In most cases internationally
(nations like Switzerland, Austria etc with highly developed agricultural
inspection and research regimes are exceptions and have as a result taken a
conservative view of the desirability of transgenic crops), regulations have
become a one way street that facilitates introduction of transgenic crops
with little counterbalance. Democratic regulatory interaction is undermined.

Also, the cost of rigorous regulation is clearly onerous, especially on
developing nations and a principle of 'user pays' must be established. The
user must be the party responsible for introducing the product into the
market. However, it is difficult to divorce 'user pays' from buying or
compromising objectivity in oversight practice. The cost of regulating
transgenic crops bears closer examination. Segregation costs are passed on
to consumers against a marked reluctance to introduce even a functional or
meaningful international labelling regulatory framework. While consumers
contribute directly to the cost of regulation and biosafety monitoring
inspections, it appears that tails they loose, heads they pay.

Regulation of anything, be it guns, chemicals or transgenic organisms, must
be meaningful and democratically consultative and accountable. The present
international regulation of transgenic crops is neither.

The ironic tragedy is that the real potential of agricultural biotechnology
is being marginalised by those who 'promote' it. Contrary to assertions made
in this debate (C Kameswara Rao, Message 54, May 16) and elsewhere, most of
those questioning the rationale and methodology governing existing GE crops
are not opposed to biotechnology or technological innovation per se. On the
contrary.

Glenn Ashton, Ekogaia Foundation, Box 222, Noordhoek, Cape Town
South Africa, +0027+21-789-1751, ekogaia (at) iafrica.com

11. Message No. 68:

This is from C Kameswara Rao, Bangalore, India.

The Principle of Substantial Equivalence (SE) and Genetically Engineered
Organisms (GEOs):

The Food and Drug Administration (FDA) of the US used the Principle of SE
for decades to assure the public of the safety of foods (and drugs). The
stringency of the regulatory oversight and safety standards of the FDA are
regarded as high, and most other countries routinely approve drugs and
pharmaceuticals on the basis of approval by the FDA. Subsequently, the
Principle of SE has been applied to foods and other products from GEOs, to
assure the consumer that the product is 'substantially equivalent' to its
conventional counterpart and that it is safe for human consumption. This
certification refers only to the product and not the process of its
production,

The FDA has long considered GE plants to be substantially equivalent to
conventional varieties and has published a policy statement to the effect
that no other regulatory review to assure the safety of foods from GEOs is
deemed necessary. However, taking advantage of the provision for voluntary
consultation, biotech companies in the US seek independent certification by
FDA of all GEO varieties and their products that are marketed in the US.

The policy of the FDA did not result in any health concerns but invited
criticism on account of
a) the FDA has a mandatory process for approving transgenic animals, and
b) the United States Environment Protection Agency (EPA) and the United
States Department of agriculture (USDA) have a mandatory and open process
for evaluating the biosecurity of transgenic plants. 

Foods from GEOs on the US markets have been tested extensively and judged
substantially equivalent to their conventional counterparts. This is the
case with many products from GEOs, such as cotton oil, tomato and corn from
Bt varieties. Some products may contain miniscule quantities of one or two
additional proteins, which are broken down during processing or digestion,
or some others may contain some compounds not occurring in the counterparts
that are present but below threshold levels. Such products are categorised
as 'Generally Recognised As Safe' (GRAS). A factor that would cause a
product to be considered otherwise is the presence of genes in the GEO or
its product, which would code for fats, proteins or carbohydrates that may
be toxic or may cause allergies or may change the nutritional value of the
product. Bt potato is one such where the gene expresses in the tuber, but
this has been tested and considered safe. For these reasons, a product can
be certified as substantially equivalent to its counterpart only after an
extensive analytical study.

Certifying a product as SE or GRAS is to assure the consumer that the food
is safe to consume. While in the US, on account of the policy of the FDA, no
labelling as SE or GRAS is mandatory, it is not so in several other parts of
the world. This dichotomy causes considerable confusion in the global
policy, and leads to needless controversies.   There is a dire need for
international harmonisation and uniform policy.  

In recent times suggestions were made for the application of the Principle
of SE to all products of genetic engineering, including livestock feed and
GE crops, which raises certain questions.

When the principle of SE is applied to a GE crop variety, it should be
substantially equivalent to its isogenic variety, in genotype, marked
characters and performance, but for the transgenes and their anticipated
characteristics and benefits. [Isogenic lines are genetically nearly
identical, except with respect to identified genes...Moderator]. The
objective is that, if the isogenic was safe, the transgenic would be equally
safe, provided that the newly introduced transgenes do not exercise any
adverse effects by themselves or through affecting the expression of any
other genes of the isogenic counterpart. Such an assurance requires
scientific evaluation of the crop variety first, and then of its products.
This involves additional efforts, time and expense, raising costs to the
consumer.  

All US agricultural biotechnology companies submit to the FDA, voluminous
dossiers on the safety and risk analysis of the GEOs and their derivatives
produced by them before they go on the US markets. Such a voluntary
mechanism should be global. However, like drugs and pharmaceuticals, what is
considered safe in one country should be so in other countries, provided
uniform testing procedures are adopted. There is no need to repeat every
test in every country.

Another consideration is that transgenics would be substantially equivalent
to their isogenics, up to a point in real time. Mutations occur naturally
and randomly, affecting all genes. Members of the same population would be
subjected to mutation of different genes and so would not be entirely
identical with each other. Lethal mutations are naturally eliminated. If any
genes related to the desired characteristics mutate, they are eliminated in
the process of selection, but those that do not affect the desired
characteristics escape attention and accumulate. After a certain number of
generations, SE cannot be maintained for the entire genotype of all members
of population. A critical genetic analysis at that point of time will
contravene SE, although SE can be established for the genes of the desired
characteristics. Such a situation would cause problems in some countries,
where the regulatory authorities apply the principle in letter and a lot
more strictly than in other countries.  

On account of these reasons there is a need to re-examine the issue of SE
and for re-defining its applicability to GE crop plants and their products,
laying emphasis on a reasonable application of the principle, addressing
only      those genes and their products that are relevant to the objectives
of developing a particular transgenic variety or product.

Since the objective of technology deployment is improvement of a product
over what exists, the question should be 'is this better and safer than what
is already there?'

12. Dear Professor Rao,
 
Thanks for this message, bringing the important topic of substantial
equivalence plainly into the arena.
 
The messages was nearly 1000 words. Please keep in  mind the 600-word limit
if posting any further messages.
 
Sincerely
 
Moderator, Conference 9

13. (not posted at the FAO conference)

This is with reference to message No. 49, from Dr Jasper Buijs and the questions he raised.

Right now it is far too expensive and time consuming to use transgenic
Technology to develop new crops specifically for small-scale farmers.  
Any crop plant variety, conventional or transgenic, should suit the specific
agro-climatic conditions.   In some of the developing countries, a very large
number of locally adoptable varieties of the same crop, are needed.   With more advances in technology allowing the production of transgenics with a much
greater ease and rapidity than now, this should be possible, probably in a
decade or so.  
  
Unmonitored and prolific sharing of propagation material can lead to an uncontrolled spread of genotypes.   If such sharing can be limited to narrow areas, even within a particular agro-climatic zone, the problem can be contained. This requires extensive farmer education.
A ten-year study in UK by Michael Crawley and team  (Nature, February 8, 2001) has shown that GE crops such as maize, beet, oilseed rape and potato, did not become more competitive than their non-GE counterparts and did not invade the environment.  None of the GE-crops survived beyond the fourth year, even within the cultivated field.
In controlled field trials of GE crops, gene flow was less than two per cent.   No reports indicate any significant gene flow under commercial cultivation of GE crops.   Gene flow depends upon a number of factors, such as the duration of viability of the pollen, and of the receptivity of the stigma, breeding behaviour of the cultivated variety (not that of the wild populations), the pollen vectors and the aero-dynamics of the pollen determined by size, morphology, wind currents, etc.   Gene flow to other non-GE varieties of the same crop or to its wild related species, from the respective GE crop varieties, would be no less and no more than between varieties and related wild species of non-GE crops, growing in the same area.   Transgenic varieties are not more promiscuous than their non-transgenic counterparts.   Even if a few isolated inter-crossings occur they are of no significance.   There must be introgression (repeated backcrossing between the same set of lines) and the gene(s) thus transferred should have an adaptive value, for such gene flow to be significant in any manner.   It should be remembered that gene flow could also occur in the reverse direction—from non-GE to GE varieties.   Prevention of reverse gene flow would soon be a major worry of the farmers cultivating trangenics. 

Deployment of transgsenics in centres of origin and/or diversity is a question that has to be determined, case-by-case, in order to ensure public confidence.   With due caution, it is possible to introduce transgenics safely into these areas, without unduly undermining the diversity.   If that diversity were to be so fragile, it would not be occurring today.   The report of contamination of local varieties of corn by transgenic corn in Mexico, published in Nature last year, was retracted on the basis of inappropriate methods and inadequate scientific evidence.   If there was a chance of outcrossing, farmers do know how to by pass it.   They have been maintaining for centuries such crops as cabbage, cauliflower, knoll-kohl, Brussels’ sprouts and broccoli, which are varieties of a single species and which inter-cross very easily, soon losing their respective identities, if not isolated from each other.    It is science, and not mere sentiment, that should determine our action with regard to centres of origin/diversity of crop plants.
Whenever new varieties of crops, high yielding, pest or pathogen resistant or otherwise advantageous to the cultivation and/or the consumer, were introduced, certain amount of neglect and consequent loss of landraces has occurred, even before the advent of transgenics.   When a particular crop variety is cultivated endlessly, without any kind of improvement, it is bound to degenerate in course of time.   We have to determine if any of the landraces are more beneficial to the cultivator and/or the consumer, than the other available options, and whether they deserve to be conserved.   If so, farmers and scientists would readily conserve them.   Conservation for the sake of conservation or conservation on the remote chance of the traits of the conserved varieties becoming more beneficial, in future, than the traits in varieties that are currently in wide cultivation, are arguments that attract only a few.   In the final analysis, conservation issues revolve around economics and so politics is not far behind.